Ignite Biomedical
Regulation Crowdfunding offering on StartEngine
$174,282
of $1.24M goal
14.1% funded
About the offering
We are currently in the early development stages of our products, with our TNFi treatment response predictor test passing the first step of test development, analytical validation. Strong Market Position: To our knowledge, there is currently only one TNFi response test available in the market, which we believe has a higher error rate, is limited to patients with rheumatoid arthritis, which positions us well to capitalize on early-mover advantages in a high-growth market. Validation: Early studies suggest our test has close to 100% accuracy in detecting response and non-response.* Strategic Partnerships: Our partnership with Liquid Biosciences and SmartHealth Diagnostics enables us to bring products to the market efficiently to meet the growing demand for high-quality biomarker tests. *The accuracy results cited are based on retrospective validation using third-party datasets and may not be indicative of future clinical performance. Further prospective validation studies are planned. Ignite Biomedical’s TNFi diagnostic test has completed analytical validation and is currently in early development, with clinical validation and commercial availability still pending. THE PITCH Delivering on the Promise of Precision Medicine We are focused on the development of AI-driven biomarkers for precision medicine in conditions related to autoimmune disease and behavioral health. Our blood-based tests utilize mRNA biomarkers to predict the likelihood of therapy response, with results in 24-48 hours. Our CEO Claudio Faria and CMO Jake Nichols both hold Doctorates from Massachusetts College of Pharmacy, and Master’s degrees from the University of Massachusetts. Driven by the scientific and business experience of our key executives, we are planning to disrupt the current healthcare operating model by creating a platform for clinicians to provide the right therapy for the right patient at the right time. Our Tumor Necrosis Factor Inhibitor (TNFi) test is designed to address a sizable market opportunity estimated at over $1.2 billion, which only considers first-time users(1). We have raised $1.5 million in a pre-seed round and are seeking $10 million in our next funding round. The initial commercial launch for our TNFi biomarkers is planned for early 2027, contingent upon successful completion of development. Our main products are patent protected through 2038, allowing us to enjoy potential long-lasting competitive advantages during the commercialization phase. THE PROBLEM Solving a Trillion-Dollar Problem Across FDA-approved products, only 36% of patients respond to therapy.** The remaining patients that do not respond represent an annual spend of nearly $2 trillion*** for zero benefits with a high risk of side effects. Our goal is to improve patient care, optimize clinical outcomes, and eliminate waste. Our joint venture partner's proprietary platform Emerge®, employing next-generation evolutionary computing, is designed to accurately discover algorithmic biomarkers for identifying patients who will respond and not respond to therapy, matching the right patient with the right therapy at the right time. **This estimate is based on the Company’s analysis of published response rates from Nature, PMC, and Forbes, using a conservative averaging approach. ***This estimate reflects internal modeling based on public healthcare cost data and assumptions about the impact of non-response. In 2022, TNFi therapies, which target conditions such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis, generated revenue of more than $30 billion in the US. However, 70% of patients who received these treatments did not achieve the desired outcome from the prescribed therapies. Data also shows that more than 50%*** of patients discontinue prescribed TNFi within a year of starting treatment due to the ineffectiveness of these medications to achieve meaningful results. Our treatment response predictor is designed to eliminate these unnecessary costs, improve patient outcomes, and empower clinicians to make better individualized treatment decisions. ***This figure is based on proprietary claims data analyzed by the Company, supported by publicly available secondary sources. *These milestones are forward-looking and based on current plans and assumptions. Actual results may differ due to a variety of factors. THE MARKET & OUR TRACTION Leveraging Precision Testing for Market Expansion TNFi treatments can cause serious, life-threatening side effects, leading to an additional $9 billion in annual spending.**** We believe our TNFi treatment response predictor (TRP) has the potential to save billions of dollars being spent for no reason. Our foundational TNFi predictor is intended to provide platform validation for all future tests, and we are planning to build on the success of the TNFi TRP blood test to expand into other immunology market opportunities. As part of our commercialization strategy, our next step is to publish our discovery data and validation results in peer-reviewed journals to facilitate dissemination to clinicians who prescribe TNFi therapies. ****This estimate is based on the Company’s internal analysis of published studies on treatment non-response, disease progression, and adverse event costs associated with TNFi therapies. Our long-term objective is to build a differentiated portfolio of AI-supported biomarker tests to help patients find the most effective treatments for their underlying health conditions efficiently and accurately. Our future target markets include biomarkers for substance use where Americans spend $700 billion annually and other behavioral health challenges. We have several other exciting products in our pipeline, including a diagnostic and prognostic blood test for IBD, a second treatment response predictor in IBD, and a portfolio of biomarkers for rheumatoid arthritis.
FAQ
How much has Ignite Biomedical raised?
Ignite Biomedical has raised $174,282 of a $1.24M goal.
Where is Ignite Biomedical's campaign listed?
The offering is listed on StartEngine, an SEC-registered Reg CF intermediary.
What are the terms of Ignite Biomedical's raise?
Convertible Debt, $20M cap.
When does Ignite Biomedical's offering close?
The stated close date is Jul 23, 2025.
